1. Field Of The Invention
This invention relates to a drug storage and delivery system that affords sterile access and delivery of the contents of a drug-containing vial assembly. More particularly, the invention relates to a drug storage and delivery system that includes a unique adapter assembly to connect a drug-containing vial assembly to a syringe assembly used to transfer a diluent into the vial assembly and/or to transfer the contents from the vial assembly.
2. Description Of The Prior Art
Medicaments or drugs normally administered in a health care environment, being flowable substances, are typically packaged in vials whose interior is maintained in a sterile condition. The vials themselves are sealed by a sterile stopper that is eventually pierced by a cannula when it is desired to remove the medicament or drug. Several procedures are required in order to remove the drug from the vial and administer it to a patient. Each procedure is time consuming for health care personnel and more importantly each procedure presents a risk of jeopardizing the sterility of the vial, the stopper or the medicament.
If the drug in a particular vial is a powder, the procedures that may jeopardize sterility include adding diluent to the vial to dissolve the powder, withdrawing the reconstituted drug from the vial, and then subsequently further diluting the concentrated drug solution to the desired strength. When the medicament or drug can be administered directly to a patient, a cannula and syringe assembly may be used to make an injection through the skin of the patient or into a Y-site in an I.V. administration set. If the medicament or drug is of such a strength or potency that it must be administered over a prolonged period of time then the medicament or drug is mixed with a large quantity of diluent and placed into a container which becomes a secondary fluid source in a piggyback I.V. administration system. Alternatively, the reconstituted drug may be administered from a syringe using an electromechanical pump. If there is no primary fluid source in an I.V. administration system the drug and diluent solution may itself be administered intravenously to a patient.
The problem, therefore, experienced by health care and pharmacy personnel with prior art drug delivery systems is three-fold. First, multiple time consuming procedures are required in order to take the drug from its storage condition in a pharmacy to a condition in which it can be properly and safely administered to a patient. Second, each procedure between storage and administration presents a new opportunity for jeopardizing drug, stopper or vial sterility. Third, the time between mixing and use is limited to typically one day, due to loss of potency for the mixed drug.
A system is disclosed for storage and delivery of a drug that successfully minimizes the possibility of contamination of the drug, the vial and the stopper between storage and administration in U.S. Pat. No. 4,614,515, which patent is assigned to the same assignee as the present invention. In this system the drug or medicament is sealed within a vial by a removable stopper in the vial opening. Positioned over the stopper in the vial opening is a removable diaphragm. Circumscribing the outside of the vial is a skirt member, which is in frictional contact with the wall portion of the vial. The diaphragm is connected to the skirt member so that access to the interior of the vial may be obtained by either separating the diaphragm from the skirt member and piercing the stopper with the point of a cannula, or separating the diaphragm from the skirt member and removing the stopper from the vial opening. The separation of the diaphragm from the skirt member is accomplished by the use of fragile sections circumscribing that portion of the skirt member, which connects the portion of the skirt member in frictional contact with the wall portion of the vial and the diaphragm. Once the diaphragm has been removed from its position over the stopper, the stopper may be removed from the vial and the contents of the vial added to an intravenous administration system without compromising sterility of the drug, the vial or the stopper.
A system disclosing an apparatus for making a direct addition of a medicament or drug to a flexible container for eventual use as either a primary or secondary fluid source in I.V. therapy is disclosed in U.S. Pat. No. 4,614,267, which patent is also assigned to the same assignee as the present invention.
There is a need for facilitating the connection of such a vial to a syringe assembly. There is also a need for facilitating the introduction of a diluent into the drug-containing vial of such a system. There is further a need to provide the above capability for activation at the point of use so as to minimize the time between mixing and delivery to the patient.